# K952524: Aesculap Biopolar Coagulator

- Pathway: 510(k) (Traditional)
- Applicant: Aesculap, Inc.
- Decided: Jun 29, 1995 after 28 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K110695: Bipolar HF Device (2011), 0 descendants of its own

## Recalls of this device
- Sep 10, 2013 · Class II · Z-0479-2014: Complaints were received for the GN161 Bipolar Foot Control reporting that the bipolar energy did not stop after release of the foot control.

Source page: https://510kreport.com/device/K952524
Methodology: https://510kreport.com/methodology